PARACETAMOL DOC*20TAB 500MG

PARACETAMOLO DOC Generici 500 mg tablets

What it is and what it is used for
PARACETAMOLO DOC Generici contains the active ingredient paracetamol, belonging to a group of medicines known as analgesics and antipyretics, as they act by relieving pain (analgesic action) and lowering body temperature in case of fever (antipyretic action).
PARACETAMOLO DOC Generici is used to lower fever and relieve mild to moderate pain.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take PARACETAMOLO DOC Generici:
- if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe kidney problems (severe renal failure);
- if you abuse alcohol.

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO DOC Generici. Never exceed the recommended dose.

Take this medicine with caution:
- if you suffer from liver problems such as liver failure, Gilbert's syndrome (an inherited disease characterized by yellowish skin discoloration) or acute hepatitis and if you are taking other medicines that alter liver function;
- if you suffer from hemolytic anemia, characterized by a low number of red blood cells in the blood;
- if you abuse alcohol, in this case the dose should be reduced (see section 3 - Use in people suffering from chronic alcoholism);
- if you have severe kidney problems (severe renal failure);
- if you have a rare inherited disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase;
- if you weigh less than 50 kg;
- if you suffer from malnutrition and dehydration.

During treatment with PARACETAMOLO DOC Generici, inform your doctor immediately if:
- you suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a severe condition called metabolic acidosis (an abnormality of blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with rapid deep breathing, drowsiness, nausea and vomiting.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take other products containing paracetamol at the same time.

Do not take higher doses than recommended because a higher dose does not increase pain relief, but can instead cause severe liver or kidney damage (analgesic nephropathy). For this reason, contact your doctor as soon as possible if you have taken more PARACETAMOLO DOC Generici than recommended in this leaflet.
Sudden discontinuation of analgesics after a prolonged period of incorrect use at high doses can cause headache, fatigue, muscle pain, nervousness and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not resume taking them without consulting your doctor.

Taking this medicine may alter the results of some laboratory tests such as the measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur, classified below according to frequency:

Rare (may affect up to 1 in 1,000 people):
- alterations in the production of blood components (bone marrow depression): alterations in platelet levels, stem cell diseases, reduction of red blood cells (non-hemolytic anemia);
- allergies (excluding angioedema), bronchospasm (more likely in asthmatic subjects sensitive to aspirin or NSAIDs);
- depression, confusion, hallucinations;
- tremor, headache (cephalalgia);
- altered vision;
- fluid accumulation and swelling (edema);
- bleeding (hemorrhage);
- abdominal pain, diarrhea, nausea, vomiting;
- pancreatic diseases (acute and chronic pancreatitis, exocrine pancreatic diseases);
- liver problems (impaired liver function, liver failure, hepatic necrosis), yellowish discoloration of the skin and whites of the eyes (jaundice);
- itching, skin rashes, sweating, bruising (purpura);
- swelling of the face, tongue and throat (angioedema), urticaria;
- dizziness, malaise, fever, sedation;
- overdose and poisoning;
- kidney alterations (severe renal failure, interstitial nephritis, hematuria, anuresis).

Very rare (may affect up to 1 in 10,000 people):
- liver damage (hepatotoxicity);
- allergic reactions;
- reduction of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia) and red blood cells (hemolytic anemia) in the blood;
- reduction of blood sugar levels (hypoglycemia);
- sterile pyuria (cloudy urine) and kidney problems;
- severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).

Not known (frequency cannot be estimated from the available data):
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients suffering from a severe illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.